Newsletter | November 13, 2025

11.13.25 -- AbbVie And Amgen's Blueprint To Digitalize Biomanufacturing

SPONSOR

High Cell Density Cryopreservation (HCDC) enhances seed train intensification in biomanufacturing by allowing the storage and controlled freeze-thaw cycles of concentrated cell cultures. This method eliminates traditional expansion steps, significantly reducing the time required for inoculating production bioreactors. HCDC also minimizes contamination risks through closed processing in single-use cryobag assemblies, improves reproducibility, and streamlines processes by decoupling cell expansion and batch production, ultimately increasing efficiency and flexibility. Request a sample of an HCDC Bag assembly!

FOCUS ON MANUFACTURING CONTROLS

AbbVie And Amgen's Blueprint To Digitalize Biomanufacturing

At BioProcess International 2025, leaders from AbbVie and Amgen gave keynote presentations about how their companies are advancing product development through digital tools.

AACR 2025 Interview Series: Sizun Jiang

Discover Dr. Sizun Jiang's transformative insights on spatial technologies, AI-driven cancer care, and data harmonization, which illuminate the future of oncology through innovation.

Validation 4.0 In The Life Sciences Industry

Discover how Validation 4.0 is revolutionizing manufacturing by merging smart technologies, real-time data, and regulatory alignment to drive efficiency, accuracy, and innovation.

A Guide To EAM/CMMS Selection For Contract Manufacturers

CDMOs face rising complexity in multi-client operations. Learn how modern EAM and CMMS systems enable agility, compliance, and scalability to transform asset management into a strategic advantage.

Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer

Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency and innovation in bioprocessing workflows.

Navigating Technology Transfer In Manufacturing

Technology transfer is essential for scaling life sciences innovation. Learn how teams navigate its complexity, overcome common challenges, and leverage digital tools to improve quality.

Frequently Asked Questions: New Cloud-Based Monitoring Platform

Monitor assets in real-time, anticipate issues, and maintain optimal performance effortlessly by exploring a cloud-based asset monitoring platform that offers proactive support and rapid response from experts.

Engineering Excellence: A Partnership Drives Innovation, Local Growth

JHS and groninger’s partnership powers expansion with advanced aseptic filling lines, driving innovation, quality, and community growth through shared values and strategic collaboration.

MANUFACTURING CONTROLS SOLUTIONS

Reduce The Burden Of Software Validation Testing - ValGenesis

Process Knowledge Management: Recipe Management In A Digital Plant - Emerson

The Future Of GxP Manufacturing With AI - Aizon

The Power Of DataOps And Unified Namespace In Unlocking AI For Pharma 4.0 - HighByte

FOCUS ON FACILITIES DESIGN

The Interoperability Challenge In Single-Use

In this segment from the Bioprocess Online Live event, “Single-Use Harmonization Needs A Tune Up,” our panelists define the main challenge plaguing single-use users: a lack of standards across systems and components. This absence of standardization creates a demand for deep, system-specific expertise that complicates interoperability across the industry and even within an organization. They discuss the many layers of nuance and complexity that make large-scale standardization difficult.

Manifolding For Scale-Up, Safety, And Speed

The use of manifolds to fill bags for bioprocessing or advanced therapies contributes to time savings, improved process quality, and optimal use of cleanroom and personnel resources.

Advanced Therapy Manufacturers' Checklist For Cleanroom Project Success

Current advances in cell, gene, and tissue therapies require a rethinking of how—and where—cleanroom manufacturing facilities could be built, enabling more options for sponsor process control.

Replacing Bleach In Removal Of DNA

Learn about an effective cleaning solution that removes DNA from laboratory equipment and materials without the need for bleach.

The Coevolution Of The Single-Use And Biopharmaceutical Industries

Learn more about the evolution of one company's solutions for biopharmaceutical manufacturing and accelerating market entrance using single-use technology.

FACILITIES DESIGN SOLUTIONS

Single-Use Bioprocessing Systems: Portfolio And Capabilities - Avantor

Pharmaceutical, Process, And Packaging Equipment - Federal Equipment Company

3D Modeling Of Facilities With Digital Twin Technology - CAI

Connect With Bioprocess Online: